(43 days)
No reference devices were used in this submission.
No
The description focuses on the material properties and intended uses of dental filling composites, with no mention of AI or ML.
No
The device, Visalys® Bulk Fill / Flow, is described as a light-cured, nano-hybrid filling composite used for restoring tooth substance. Its purpose is to replace lost tooth material rather than to treat or cure a disease or medical condition.
No
Explanation: The device is a dental filling composite used for restoring tooth substance loss, not for diagnosing medical conditions. Its intended use focuses on treatment and repair, not detection or assessment of diseases.
No
The device description clearly states it is a light-cured, nano-hybrid filling composite material, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for restoring tooth substance loss and performing various dental restoration techniques. This is a direct treatment applied to the patient's tooth.
- Device Description: The device is a filling composite material used for dental restorations.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples. It is a material used to physically repair a tooth.
Therefore, Visalys® Bulk Fill and Visalys® Bulk Flow are dental restorative materials, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.
Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.
Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance: According to ISO 4049 "Polymer-based restorative materials" bench testing was performed to allow an evaluation of the mechanical properties of Visalvs® Bulk Fill and Visalys® Bulk Flow in comparison to Venus Bulk Flow ONE (K220605). Key results: The tests showed that the biocompatibility data of Visalys® Bulk Flow (and therefore Visalys® Bulk Fill) is comparable to other materials on the market. Hence, no toxicological risks and resulting hazards for patients, users and third parties can be concluded. A comparison of the parameters in respect to mechanical properties was performed. The results demonstrate the substantial equivalence to the predicate device.
Clinical Performance Data: Data from clinical studies was not provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
March 14, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Kettenbach GmbH & Co. KG Marleen Steger Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, 35713 Germany
Re: K250267
Trade/Device Name: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 13, 2025 Received: March 13, 2025
Dear Marleen Steger:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K250267
Device Name
Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
Indications for Use (Describe)
Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.
Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features six blue circles arranged in a triangular pattern above the text "KETTENBACH DENTAL" in a bold, blue font. Below the company name is the tagline "Simply intelligent" in a smaller, lighter blue font.
K250267 - 510(k) Summary
l. Submitter:
Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany
Phone: +49 2774 705 0 Fax: +49 2774 705 66
Contact person:
Steger, Marleen Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: marleen.steger@kettenbach.com
Date of preparation:
March 14th, 2025
| II.
| Device | |
|---|---|
| Name of Device: | Visalys® Bulk Fill |
| Common or Usual Name: | Visalys® Bulk Fill |
| Classification Name: | Material, Tooth Shade, Resin (21 CFR 872.3690) |
| Regulatory Class: | II |
| Product Code: | EBF |
| Name of Device: | Visalys® Bulk Flow |
| Common or Usual Name: | Visalys® Bulk Flow |
| Classification Name: | Material, Tooth Shade, Resin (21 CFR 872.3690) |
| Regulatory Class: | II |
| Product Code: | EBF |
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Image /page/5/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of a geometric design of six circles arranged in a triangular pattern above the company name. The text "KETTENBACH" is in a bold, sans-serif font, with "DENTAL" in a lighter, smaller font next to it. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.
= Predicate devices:
Venus Bulk Flow ONE (Kulzer, LLC), K220605 This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. Device Description:
Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.
Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.
*Aluminium has the same radiopacity as dentin. 1 mm enamel corresponds to 2 mm aluminium.
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Image /page/6/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue graphic of seven circles arranged in a triangular shape above the company name. Below the company name is the tagline "Simply intelligent" in a smaller font size.
> Indications for Use:
Visalys® Bulk Fill
Loss of tooth substance due to caries, fractures, dental wear or developmental disorders.
Techniques:
- Class I and II restorations .
- Non-tunneled class III restorations ●
- Class V restorations ●
- Fillings in deciduous teeth
- Core build-ups
- Cavity floor elevation ●
- Repair of direct and indirect restorations after appropriate pretreatment ●
- Splinting / locking of teeth ●
Visalys® Bulk Flow
Loss of tooth substance due to caries, fractures, dental wear or developmental disorders.
Techniques:
- . Class I and II restorations
- Non-tunneled class III restorations ●
- Class V restorations ●
- Fillings in deciduous teeth ●
- Core build-ups ●
- Cavity lining ●
- Cavity floor elevation ●
- Blocking out undercuts
- Repair of direct and indirect restorations after appropriate pretreatment ●
- Extended fissure sealing ●
- Splinting / locking of teeth ●
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| imply intelligent
1
| e |
|---|
| ---------------------------------- |
able 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Predicate Devices | Substantial Equivalent Device | Conclusion | ||
|---|---|---|---|---|
| Venus Bulk Flow ONE | Visalys® Bulk Fill | Visalys® Bulk Flow | ||
| Product | ||||
| Manufacturer | Kulzer, LLC | Kettenbach GmbH & Co. KG | ||
| Product | ||||
| Description | Venus Bulk Flow ONE is a | |||
| flowable, light-curing, radio- | ||||
| opaque nano-hybrid | ||||
| composite. | Visalys® Bulk Fill is a | |||
| light-cured, nano-hybrid | ||||
| filling composite that can | ||||
| be modeled and is | ||||
| available in a universal | ||||
| shade. | Visalys® Bulk Flow is a | |||
| light-cured, flowable | ||||
| nano-hybrid filling | ||||
| composite and is | ||||
| available in a universal | ||||
| shade. | Visalys® Bulk Fill and | |||
| Visalys® Bulk Flow are | ||||
| similar to Venus Bulk Flow | ||||
| One. All are light-cured | ||||
| nano-hybrid composites. | ||||
| Intended purpose | Flowable light curing nano | |||
| hybrid composite, radio- | ||||
| opaque | Universal nano-hybrid | |||
| restorative composite, | ||||
| modelable | Universal nano-hybrid | |||
| restorative composite, | ||||
| flowable | Visalys® Bulk Fill and | |||
| Visalys® Bulk Flow are | ||||
| similar to Venus Bulk Flow | ||||
| One. These are light-cured, | ||||
| nano-hybrid composites. | ||||
| Visalys® Bulk Fill is | ||||
| modelable, Visalys® Bulk | ||||
| Flow and Venus Bulk Flow | ||||
| ONE are flowable. The | ||||
| differences in viscosity | ||||
| have no effect on the | ||||
| intended purpose. Visalys® | ||||
| Bulk Fill and Visalys® Bulk | ||||
| Flow are radio-opaque like | ||||
| Venus Bulk Flow ONE, | ||||
| which is not described in | ||||
| the intended purpose. | ||||
| Indications / | ||||
| Techniques | - Class -I, -II, -III and -V | |||
| direct restorations |
- First-layer lining for class I
and II cavities - Repair of direct and
indirect restorations in
combination with a suitable
adhesive - Splinting loosened teeth
resulting from trauma or
periodontal associated
events | - Class I and II
restorations - Non-tunneled class III
restorations - Class V restorations
- Fillings in deciduous
teeth - Core build-ups
- Cavity floor elevation
- Repair of direct and
indirect restorations after
appropriate pretreatment | - Class I and II
restorations - Non-tunneled class III
restorations - Class V restorations
- Fillings in deciduous
teeth - Core build-ups
- Cavity lining
- Cavity floor elevation
- Blocking out undercuts | All Venus Bulk Flow ONE
indications are covered by
Visalys® Bulk Fill and
Visalys® Bulk Flow.
Visalys® Bulk Fill and
Visalys® Bulk Flow can
also be used for fillings in
deciduous teeth, core
build-ups, cavity floor
elevation and blocking out
undercuts (just Visalys®
Bulk Flow). |
| 510k Summary | | Rev.2 | | Page 4 von 8 |
510k Summary Issued: 2025-03-14
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Image /page/8/Picture/4 description: The image contains the logo for Kettenbach Dental. The logo consists of a blue triangle made of circles, with the text "KETTENBACH DENTAL" written vertically next to it. Below the company name, the words "Simply intelligent" are written in a smaller font. The image also contains the words "STEPH Production Station of Controller Station of Controller Station of Controllers of Controllers of Controllers of Controlle".
| Product | Manufacturer | Predicate Devices
Venus Bulk Flow ONE
Kulzer, LLC
- Extended fissure sealing | Substantial Equivalent Device
Visalys® Bulk Fill
Kettenbach GmbH & Co. KG - Splinting / locking of teeth | Visalys® Bulk Flow | Conclusion | |
|---------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Basic formulation | Venus Bulk Flow ONE is a
light-curing methacrylate-
based formulation with the
following ingredients:
Barium aluminium boro-
fluoro-silicate glass,
E4BADMA, UDMA,
ytterbium fluoride, silicium
dioxide, titanium dioxide,
BHT, aminobenzoic acid
ester, camphorquinone,
fluorescent pigments, metal
oxide pigments, organic
pigments. Venus Bulk Flow
ONE contains approx. 41 %
filler by vol., the particle size
of which is 20 nm – 5 µm. | Main components of
Visalys® Bulk Fill are
approx. 61 vol. %
inorganic fillers in the size
range 0.01 – 5 μm
including ytterbium
fluoride. The polymer
base consists of aliphatic
dimethacrylates. | - Repair of direct and
indirect restorations after
appropriate pretreatment - Extended fissure sealing
- Splinting / locking of
teeth
Main components of
Visalys® Bulk Flow are
approx. 47 vol. %
inorganic fillers in the size
range 0.01 – 5 μm
including ytterbium
fluoride. The polymer
base consists of aliphatic
dimethacrylates. | The basic formulation is
similar. The products are
methacrylate based and
contain inorganic fillers
including ytterbium
fluoride. The particle sizes are the
same. | |
| | Available shades | Universal shade | Universal shade | Universal shade | The products are available
in a one-shade system for
all tooth shades. | |
| | Single use | Single use only | Single use only | Single use only | The products are single
use devices. | |
| | Application system | Syringe (2 g) | Syringe (4 g)
Cap (0.25 g) | Syringe (2 g)
Cap (0.25 g) | All products are available in
a syringe. Visalys® Bulk Fill
and Visalys® Bulk Flow are
also offered in a cap. | |
| | Performance
testing | A comparison of the parameters in respect to mechanical properties was performed. The results demonstrate the
substantial equivalence to the predicate device. | | | | |
| | Summary of
Product | The indication of the subject devices is the same for the predicate device. Contraindications, application, and side
effects for both products are basically the same – there is a slight difference in the wording. | | | | |
510k Summary Issued: 2025-03-14
9
Image /page/9/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue triangle made up of six circles on the left, with the text "KETTENBACH DENTAL" to the right of the triangle. Below the company name is the slogan "Simply intelligent".
| Predicate Devices | Substantial Equivalent Device | Conclusion | ||
|---|---|---|---|---|
| Product | Venus Bulk Flow ONE | Visalys® Bulk Fill | Visalys® Bulk Flow | |
| Manufacturer | Kulzer, LLC | Kettenbach GmbH & Co. KG | ||
| Description, | ||||
| Intended purpose | ||||
| Indications, | ||||
| Contraindications / | ||||
| Precautions | ||||
| Summary | ||||
| Chemical | ||||
| Composition | The Visalys® Bulk Flow formulation has been thoroughly assessed for biocompatibility. The results for Visalys® Bulk | |||
| Flow covers Visalys® Bulk Fill since the most relevant ingredients from a toxicological standpoint are present in a | ||||
| higher concentration in Visalys® Bulk Flow. | ||||
| Summary of | ||||
| Finished | ||||
| Device | ||||
| Specification | The results demonstrate the substantial equivalence to the predicate device. |
10
- ●
- Toxicological risk assessment
- Chemical characterization ●
- Evaluation of biocompatibility
The tests showed that the biocompatibility data of Visalys® Bulk Flow (and therefore Visalys® Bulk Fill) is comparable to other materials on the market. Hence, no toxicological risks and resulting hazards for patients, users and third parties can be concluded.
Non-clinical performance:
According to ISO 4049 "Polymer-based restorative materials" bench testing was performed to allow an evaluation of the mechanical properties of Visalvs® Bulk Fill and Visalys® Bulk Flow in comparison to Venus Bulk Flow ONE (K220605).
| Sensitivity to light | Acc. to ISO 4049 / 7.9 |
|---|---|
| Depth of cure | Acc. to ISO 4049 / 7.10 |
| Flexural strength | Acc. to ISO 4049 / 7.11 |
| Elastic modulus | Acc. to ISO 4049 / 7.11 |
| Water sorption | Acc. to ISO 4049 / 7.12 |
| Solubility | Acc. to ISO 4049 / 7.12 |
| Shade of restorative | |
| materials | Acc. to ISO 4049 / 7.13 |
| and ISO 7491 / ANSI ADA Spec. 80 | |
| Color stability after irradiation | |
| and water sorption | Acc. to ISO 4049 / 7.13 |
| and ISO 7491 / ANSI ADA Spec. 80 | |
| Radio-opacity | Acc. to ISO 4049 / 7.14 |
| and ISO 13116 | |
| Volume shrinkage | Acc. to ISO 17304 |
| Shear bond strength to dentin | Acc. to ISO 29022 |
| Shear bond strength to | |
| restorative materials | Acc. to ISO 29022 |
| Duration of light curing | Internal test method |
| Extrusion force1) | Internal test method |
| Consistency2) | Internal test method |
| High shear viscosity1) | Internal test method |
| Low shear viscosity1) | Internal test methods |
| Universal color | In-vitro test |
VII. Performance Data:
Biocompatibility:
.
The following performance data were provided in substantial equivalence determination. The biocompatibility evaluation was conducted in accordance with ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.:
- . Cytotoxicity
- Sensitization
- Genotoxicity
-
- ISO 10993-10 ISO 10993-3
ISO 10993-5
- ISO 10993-17
- ISO 10993-18
- ISO 7405
Image /page/10/Picture/23 description: The image contains the text "Rev.2". The text is written in a simple, sans-serif font. The letters are black against a white background.
Image /page/10/Picture/24 description: The image shows the logo for Kettenbach Dental. The logo consists of six blue circles arranged in a triangular pattern above the text "KETTENBACH DENTAL" in blue. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.
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Image /page/11/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features a graphic of six blue circles arranged in a triangular shape above the company name. The text "KETTENBACH" is in a bold, sans-serif font, and the word "DENTAL" is in a lighter, slightly smaller font. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.
- Test just for Visalys® Bulk Flow; 2) Test just for Visalys® Bulk Fill Summary:
Based on the performance data, Visalys® Bulk Fill and Visalys® Bulk Flow were found to have a safety and effectiveness profile that is similar to the predicate device.
Clinical Performance Data:
Data from clinical studies was not provided.
VIII. Conclusion:
Based on similarities in technology and indications for use, together with results on nonclinical performance testing, Visalys® Bulk Fill and Visalys® Bulk Flow are substantially equivalent to the predicate device Venus Bulk Flow ONE (K220605).